Back

Validation support and IT Compliance engineer for non product softwares used in healthcare industry

Job Description

Experience:  

·      Engineering degree (Electronics/Comp. Sc.) with 4 - 5 years of experience in validation support and IT compliance which requires knowledge on medical standards like CFR 820, Part 11 regulation and IS013485 standards and also in ISO27001 standards.

Field of activity:

·      Ownership of non-product SW SOP (SHS AT SOP 803)

·      Process support for non-product SW process

·      Audit support

·      Tool service for eClassification tool covering 2nd level support for users and user training

·      If required, escalation of tool issues to SHS IT and SHS TE PLE organizations

·      Interface to AT stakeholders: collection of new demands and feedback for the tool

·      Rollout of and support for IT Directive 106 (Registration of non-medical IT applications)

Competences:

  • initiative and the ability to quickly familiarize oneself with new topics
  • high ability to understand user needs accompanied by high level of empathy for users
  • high level of cooperativeness in an international setting
  • ability to work in a cross-functional team
  • high level of proactive communicativeness
  • value-, result- and quality-oriented way of working

Methodological skills:

  • process understanding
  • classification and assessment

Technical skills/expertise (according to priority):

  • knowledge of CFR 820 and Part11 regulation and ISO 13485 standard
  • knowledge of IT compliance concepts (e.g. data privacy, IP management)
  • familiar with non-product SW tools and their intended use

Self-evident

1.       MS Office tools



Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Full-time

Can't find what you are looking for?

Let's stay connected

Can't find what you are looking for?